Therapeutic Use:

Indications for ATGAM:

Treatment of moderate to severe aplastic anemia in patients who are unsuitable for bone marrow transplantation.

Adult:

Perform intradermal test dose before initiating therapy (see literature). Do not dilute in dextrose injection or highly acidic infusion solutions. Give by IV infusion over >4hrs. 10–20mg/kg daily for 8–14 days. Additional alternate-day therapy up to a total of 21 doses can be administered. May need prophylactic platelet transfusions to maintain platelets.

Children:

Limited experience (see literature).

Warnings/Precautions:

To be administered by physicians with experience in immunosuppressive therapy and in facilities equipped with adequate lab and supportive medical resources. Discontinue if symptoms of anaphylaxis develop. Contains human plasma; monitor for possible infection transmission. Monitor for leukopenia, thrombocytopenia, or infection esp. with concomitant corticosteroids and antimetabolites. Pregnancy (Cat.C): not recommended. Nursing mothers.

Pharmacological Class:

Immune globulin.

Interactions:

Previously masked reactions may occur when corticosteroids and other immunosuppressant doses are reduced.

How Supplied:

Ampules (5mL)—5

Indications for ATGAM:

Management of allograft rejection in renal transplant patients.

Adult:

Perform intradermal test dose before initiating therapy (see literature). Do not dilute in dextrose injection or highly acidic infusion solutions. Give by IV infusion over >4hrs. Usual range: 10–30mg/kg daily. Delaying onset of allograft rejection: fixed dose of 15mg/kg daily for 14 days, then every other day for 14 days for a total of 21 doses in 28 days. Give first dose within 24 hours before or after transplant. Treatment of rejection: first dose can be delayed until diagnosis of first rejection episode. 10–15mg/kg daily for 14 days; additional alternate-day therapy up to a total of 21 doses can be given.

Children:

Limited experience. 5–25mg/kg daily.

Warnings/Precautions:

To be administered by physicians with experience in immunosuppressive therapy and in facilities equipped with adequate lab and supportive medical resources. Discontinue if symptoms of anaphylaxis, or severe and unremitting thrombocytopenia or leukopenia develop. Contains human plasma; monitor for possible infection transmission. Monitor for leukopenia, thrombocytopenia, or infection esp. with concomitant corticosteroids and antimetabolites. Pregnancy (Cat.C): not recommended. Nursing mothers.

Pharmacological Class:

Immune globulin.

Interactions:

Previously masked reactions may occur when corticosteroids and other immunosuppressant doses are reduced.